The company said today that it has submitted for FDA approval a health report that would provide its customers an assessment of their risk of having Bloom syndrome, a rare inherited disorder associated with short stature and various cancers that often result in death by the mid-20s. The FDA has agreed to accepted the submission, starting a process for a 90-day review period, during which the FDA could come back with more questions and further requirements.

From the blog post this morning:

While we are still in the very early stages of this regulatory review process, we remain committed to transparency and keeping our customers as informed as possible. This by no means is the end of the process even for this one condition. It is likely that 23andMe will hear back from the FDA regarding the material we gave to them, and, we in turn will have to respond to those questions as we move forward. We are pleased to be moving forward with the FDA and committed to our company mission of empowering individuals with their genetic information.

It's 23andMe's first submission of a health report since last November, when the FDA sent 23andMe a scathing warning letter demanding that the company stop marketing its Personal Genome Service. That $99 service gathered people's DNA-laden saliva, ran it through a gene chip from
Illumina, and sent back both ancestry information and more than 200 health reports indicating one's risk of getting or carrying the gene mutation for a disease such as cystic fibrosis or breast cancer or their response to drug therapies.

It's the latter, combined with expanded marketing efforts including a planned television ad campaign and a six-month period last year when 23andMe apparently ignored the agency, that prompted the FDA to reiterate its longstanding policy that providing what looks like disease diagnoses made 23andMe's service a medical device. That means it's subject to explicit FDA approval. Other firms such as Counsyl and Pathway Genomics offer genetic tests through doctors, which doesn't require FDA approval.

23andMe worked out an agreement with the FDA to continue selling the test, but only providing raw genetic data and ancestry information, not health reports. Since then, stung by a significant slowdown in new customer signups, the company has been talking constantly to the FDA to craft a new submission that would meet its approval. Backed by
Google (cofounded by cofounder and CEO Anne Wojcicki's husband Sergey Brin, from whom she separated last year), Russian billionaire Yuri Milner, and others to the tune of $126 million, 23andMe has also been hiring a number of experienced medical executives, including a chief legal and regulatory Officer, Kathy Hibbs.

23andMe is far from back to where it was before the warning letter, however, when it was signing up tens of thousands of new customers a month for at least one stretch last year. For one thing, this is only one report, far less than the more than 200 health reports it was providing or even the seven it applied for in 2012. The company says it wants to demonstrate that it understands the FDA approval process, and if it gets approval on this report, it would go on to submit more.

However, it first has to get the first one approved, which is likely to take many months if it gets approved at all. Approval also could carry restrictions, especially on diseases such as Alzheimer's or breast cancer that may upset or confuse people. It's possible the FDA might require such tests to go through a doctor or genetic counselor first.

That would be a blow to Wojcicki's vision of providing consumers direct control of their genetic information and by extension their own healthcare. In an interview this week before the submission was announced, she reiterated her determination to avoid undue interference from intermediaries. "We're in this for the long haul," she says.

FDA restrictions also could cause problems for 23andMe's main business model, which is to create a massive database of genetic profiles combined with data from thousands of surveys the company conducts with customers to offer pharmaceutical and academic researchers a way to do clinical trials much faster and more cheaply. If 23andMe is forced to submit reports one by one, it could take a very long time before 23andMe can offer enough health reports to attract the millions of customers Wojcicki wants in order to create a robust database.